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FDA Explains Surrogate Endpoint Table

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FDA discusses the agencys surrogate endpoint (SE) table that was mandated by the 21st Century Cures Act of 2016.

Device Safety/Performance Based Pathway Guidances

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Federal Register notice. FDA makes available three device-specific final guidance documents for the Safety and Performance Based P...

FDA OKs Genomic Alteration for Therapeutic/Food Pigs

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FDA approves Revivicors intentional genomic alteration in GalSafe pigs for use as food and human therapeutics.

Notice Corrected on Drug Development Tools Guide

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Federal Register notice: FDA corrects an 11/25 notice entitled Qualification Process for Drug Development Tools; Guidance for Indu...

FDA Withdraws 10 No-Longer-Marketed ANDAs

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Federal Register notice: FDA is withdrawing approval of 10 ANDAs from multiple applicants after they notified the agency that the ...

Comments Extended on Electromagnetic Compatibility Guide

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Federal Register notice: FDA extends the comment period on a draft guidance entitled Electromagnetic Compatibility of Medical Devi...

Bone, Reproductive/Urologic Drugs Panel Renewed

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Federal Register notice: FDA announces the renewal of its Bone, Reproductive and Urologic Drugs Advisory Committee for an addition...

Lexicon Pharma Fast Track for Neuropathic Pain

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FDA grants Lexicon Pharmaceuticals a fast track designation for LX9211 and its use in treating diabetic peripheral neuropathic pai...

Sanofi/GSK Delay Covid Vaccine Over Disappointing Data

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Sanofi and GlaxoSmithKline delay their Covid-19 vaccine program to improve immune response in older adults.

Covid-19 Vaccine EUA Granted Amid White House Pressure

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FDA grants an emergency use authorization for Pfizer-BioNTechs Covid-19 vaccine amid a White House threat for commissioner Stephen...